TALAM citalopram 20mg (as hydrobrobimide) tablet blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
30-06-2021
Summary of Product characteristics
(SPC)
16-12-2021
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
citalopram hydrobromide, Quantity: 24.99 mg (Equivalent: citalopram, Qty 20 mg)
Available from:
Arrotex Pharmaceuticals Pty Ltd
INN (International Name):
citalopram hydrobromide
Pharmaceutical form:
Tablet, film coated
Composition:
Excipient Ingredients: microcrystalline cellulose; maize starch; magnesium stearate; povidone; lactose monohydrate; crospovidone; titanium dioxide; hypromellose; macrogol 400
Administration route:
Oral
Units in package:
28 tablets
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
Treatment of major depression.
Product summary:
Visual Identification: white, oval tablet, film-coated tablet marked with C scoreline A on one side; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Authorization status:
Licence status A
Authorization date:
2013-09-09
Patient Information leaflet
TALAM – Consumer Medicine Information
Page 1 of 8
Talam
citalopram hydrobromide
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Talam. It does not
contain all the available information.
It does not take the place of talking
to your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Talam
against the benefits they expect it
will have for you.
TALK TO YOUR DOCTOR OR
PHARMACIST IF YOU HAVE ANY
CONCERNS ABOUT TAKING THIS
MEDICINE.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT TALAM IS USED
FOR
Talam contains the active ingredient
citalopram (as citalopram
hydrobromide) and is used to treat
depression.
It belongs to a group of medicines
called selective serotonin reuptake
inhibitors (SSRIs). SSRIs are
thought to work by their action on
brain chemicals called amines which
are involved in controlling mood.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY TALAM HAS
BEEN PRESCRIBED FOR YOU.
Depression is longer lasting and/or
more severe than the 'low moods'
everyone has from time to time due
to the stress of everyday life. It is
thought to be caused by a chemical
imbalance in parts of the brain. This
imbalance affects your whole body
and can cause emotional and
physical symptoms such as feeling
low in spirit, loss of interest in
activities, being unable to enjoy life,
poor appetite or overeating,
disturbed sleep, often waking up
early, loss of sex drive, lack of
energy and feeling guilty over
nothing.
Citalopram corrects this chemical
imbalance and may help relieve the
symptoms of depression.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED
FOR YOU.
Your doctor may have prescribed
this medicine for another reason.
There is no evidence that this
medicine is addictive.
However, if you suddenly stop
taking it, you may get side effects.
This medicine is available only with
a doctor's prescription.
DO NOT GIVE THIS MEDICINE TO A
CHILD OR AD
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Summary of Product characteristics
1
AUSTRALIAN PRODUCT INFORMATION
TALAM (CITALOPRAM HYDROBROMIDE) TABLET
1
NAME OF THE MEDICINE
Citalopram hydrobromide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Talam tablets contain 10 mg, 20 mg or 40mg of citalopram (as
hydrobromide).
Excipient with known effect: sugars as lactose monohydrate.
For the full list of excipients, see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
_TALAM 10MG: _White to off-white, round, plain film-coated tablets
containing 10mg citalopram (as
hydrobromide).
_TALAM 20MG_: White oval film-coated tablet containing 20 mg
citalopram (as hydrobromide), marked
C, scoreline, A on one side and blank on the other.
_TALAM 40MG: _White to off-white, oval, biconvex film-coated tablets
containing 40mg citalopram (as
hydrobromide), with ‘BL’ embossed on one side and ‘40’ on the
other.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Treatment of major depression.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Citalopram should be administered as a single daily dose. The dose may
be taken in the morning or
evening without regard for food.
ADULTS:
The starting dose is 20 mg/day. The dose can be increased in
increments of 10 mg until satisfactory
clinical response is achieved. The maximum dose is 40 mg/day. As the
treatment result in general
can be evaluated only after two to three weeks' treatment, possible
dose increases should take
place at intervals of two to three weeks.
2
ELDERLY PATIENTS:
The starting dose is 10 mg/day. The dose can be increased by 10 mg to
a maximum of 20 mg/day.
As the treatment result in general can be evaluated only after 2-3
weeks’ treatment, a possible dose
increase should take place after an interval of 2-3 weeks.
REDUCED HEPATIC FUNCTION:
An initial dose of 10 mg daily for the first two weeks of treatment is
recommended in patients with
mild or moderate hepatic impairment. The maximum recommended dosage is
20 mg/day. Caution
and extra careful dose titration is advised in patients with severely
reduced hepatic function.
REDUCED RENAL FUNCTION:
Dosage adjus
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